Pfizer and BioNTech have submitted a request to amend the emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for their COVID-19 vaccine to include a booster dose for everyone 18 years of age and older.
Pfizer said the amendment request is based on results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the vaccine, which enrolled more than 10,000 participants during a period when the Delta variant was the prevalent strain.
In October, the companies released topline results from the trial showing that a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series demonstrated a relative vaccine efficacy of 95% when compared to those who did not receive a booster.
A booster dose of the Pfizer-BioNTech COVID-19 Vaccine is currently authorized by the FDA for emergency use after completion of a primary series in individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2, as well as eligible individuals who have completed primary vaccination with a different authorized COVID19 vaccine.
